This study was to be conducted at two sites - India and Sri Lanka. At the Indian site 250 patients were to be recruited and an equal number of patients were to be recruited at the Sri Lankan site. However, to best of our knowledge the site at Srilanka is not yet operational. We wrote a number of times to Dr E Mohan Das, zone 16 representative to request the identified investigators at Sri Lankan site to coordinate with us, but till date we have not been contacted.

1. Patients with established T2DM as defined by American Diabetes Association (ADA 1997) criteria

2. Patients able to read Hindi

Exclusion Criteria

1. Patients who were too sick to participate.

2. Patients who were unable to read Hindi.

Instruments

Socio-demographic profile sheet: A proforma was designed for the study to record the relevant sociodemographic data.

Clinical profile sheet: A proforma was designed for this study to record the following clinical details: duration of diabetes mellitus, complications, anthropometry, past psychiatric history, past psychiatric treatment, family history of psychiatric disorders, etc.

Patient Health Questionnaire (PHQ): It is a standardized, brief and easy diagnostic assessment procedure designed for the busy clinician. According to the length of the questionnaire, PHQ has three versions: 2-page version (Brief PHQ) that covers only mood and panic disorder; 3-page version which covers 8 diagnoses; and the 4-page version, which in addition to the above has questions about menstruation, pregnancy, child birth, and recent psychosocial stressors. For this study, the 3-page version was used to screen as it covers the common mental disorders.

The 3-page questionnaire has questions about symptoms and signs divided into eight diagnostic categories corresponding to specific DSM-IV diagnoses. These are threshold disorders corresponding to major depressive disorder, panic disorder, other anxiety disorder, bulimia nervosa and sub-threshold disorders (in which the criteria for disorders encompass fewer symptoms than are required for any specific DSM-IV diagnosis) such as other depressive disorders, probable alcohol abuse or dependence, somatoform and binge eating disorders. There is an additional item asking about the patient’s functional status in relation to the symptoms.

Patient’s responses to the PHQ indicate to the physician, which if any, of the diagnostic categories is applicable to the patient. The evaluation by the physician can be done at any time during the encounter with the patient, but after the reasons for the patient’s visit are addressed to after evaluating each patient but before reviewing the PHQ, the physician notes whether the patient is new or established, types of current physical disorders and the physician’s opinion about any current mental disorder in the patient. The clinician then scans the completed questionnaire, verifies positive responses and applies diagnostic algorithms that are abbreviated at the bottom of each page. Before making a final diagnosis, a physician rules out any physical cause for the psychiatric disorders. Further, before diagnosing a subject as suffering from depressive disorder, the physician should evaluate the patient for the history of mania and normal bereavement10.

For the study, Hindi translation of 3-page questionnaire was used. This translation was done for one of the previous studies from our centre using standardized methodology for translation.

Procedure

All the patients with T2DM attending the Endocrinology Outpatient Clinic in Nehru Hospital, PGIMER were initially asked to fill the Hindi version of the PHQ. Informed and written consent was obtained from all the participants. Those found to fulfill any common mental disorder on PHQ were assessed further by a qualified psychiatrist, who interviewed the patients using a semi-structured interview to ascertain the psychiatric diagnosis. Subjects found to have psychiatric disorders were offered treatment. The socio-demographic and clinical data will be recorded in a systematic fashion.